Necrotic Immature Permanent IncisorsRegenerationNCT07121348
Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)
A study testing Platelet rich fibrin in people with Necrotic Immature Permanent Incisors, run by Tanta University at 1 site in Egypt.
Trial summary
the clinical trial aims to evaluate efficency of different scaffolds in cases of regeneration Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Necrotic Immature Permanent Incisors
- What is being tested?
- Platelet rich fibrin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Teeth with previous endodontic treatment.
- Teeth with internal or external resorption
- Radiographic evidence of root fracture.
- Lack of patient and parent cooperation.
- Presence of periodontal pocket depth more than 4 mm.
Trial locations and contacts
1 site in 1 country.
About this study
the clinical trial aims to evaluate efficency of different scaffolds in cases of regeneration
Read the detailed description
The aim of this study is to evaluate the clinical and radiographic outcome of regenerative endodontic procedures in immature non-vital permanent teeth using different nanoscaffolds (Platelet-rich fibrin, Mesoporous silica nanoparticles, Hyaluronic acid nanoparticles, Pomegranate nanoparticles)
- Conditions
- Necrotic Immature Permanent Incisors
- Being tested
- Platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinProcedure or surgery
Also called mesoporous silica nanoparticles, hyaluronic acid nanoparticles, pomegranate (punica granatum) nanoparticles
platelet rich fibrin is obtained by removing the middle layer from a centrifuged blood sample and is rich with platelets that plays an important role in tissue regeneration mesoporous silica nanoparticles are high surface area and excellent biocompatibility and enhance the outcome hyalurnic acid nanoparticles are high water capacity and involved in cell proliferation and adhesion and help in tissue regeneration pomegranate nanoparticles has anti-inflammatory and antibacterial effect and also help in tissue proliferation and regeneration
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin (PRF only) | Experimental | patients will recieve canal disinfection followed by induction of bleeding and placement of platelet rich fibrin as the only scaffold before coronal sealing.
platelet rich fibrin is obtained br removing the middle layer from a centrifuged blood sample and this is rich in platelets that play role in promoting tissue regeneration. Receives: Procedure: Platelet rich fibrin |
| Mesoporous Silica Nanoparticles scaffold (MSN) | Experimental | patients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing.
Mesoporous Silica Nanoparticles are biocompatible with high surface area that used as scaffold for enhancing the outcome. Receives: Procedure: Platelet rich fibrin |
| Hyaluronic Acid Nanoparticles scaffold (HA) | Experimental | patients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing.
Hyalornic Acid nanoparticles are biodegradable with high water retention capacity promoting pulp tissue regeneration. Receives: Procedure: Platelet rich fibrin |
| Pomegranate ( punica granatum) Extract Nanoparticles scaffold | Experimental | patients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing.
Pomegranate Extract Nanoparticles are synthesized from Punica granatum exract with potential antimicrobial and regenerative properties. Receives: Procedure: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
apical closure assessed radiographically
radiographic evaluation of apical closure as reduction or elimination of the apical opening of the root
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start28 Jul 2025
- Primary completion28 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Immature Permanent IncisorsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Ahmed Hashad, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121348
- Sponsor's protocol ID
- REGEN2025-NH
- Acronym
- Regeneration
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share clinical and radiograpjic outcomes with qualified researches
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07121348
- Acronym / sponsor ID
- Regeneration / REGEN2025-NH
- Conditions
- Necrotic Immature Permanent Incisors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the clinical trial aims to evaluate efficency of different scaffolds in cases of regeneration
Detailed description
The aim of this study is to evaluate the clinical and radiographic outcome of regenerative endodontic procedures in immature non-vital permanent teeth using different nanoscaffolds (Platelet-rich fibrin, Mesoporous silica nanoparticles, Hyaluronic acid nanoparticles, Pomegranate nanoparticles)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Fibrin (PRF only) | Experimental | Procedure: Platelet rich fibrinpatients will recieve canal disinfection followed by induction of bleeding and placement of platelet rich fibrin as the only scaffold before coronal sealing. platelet rich fibrin is obtained br removing the middle layer from a centrifuged blood sample and this is rich in platelets that play role in promoting tissue regeneration. |
| Mesoporous Silica Nanoparticles scaffold (MSN) | Experimental | Procedure: Platelet rich fibrinpatients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing. Mesoporous Silica Nanoparticles are biocompatible with high surface area that used as scaffold for enhancing the outcome. |
| Hyaluronic Acid Nanoparticles scaffold (HA) | Experimental | Procedure: Platelet rich fibrinpatients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing. Hyalornic Acid nanoparticles are biodegradable with high water retention capacity promoting pulp tissue regeneration. |
| Pomegranate ( punica granatum) Extract Nanoparticles scaffold | Experimental | Procedure: Platelet rich fibrinpatients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing. Pomegranate Extract Nanoparticles are synthesized from Punica granatum exract with potential antimicrobial and regenerative properties. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Teeth with previous endodontic treatment.
- Teeth with internal or external resorption
- Radiographic evidence of root fracture.
- Lack of patient and parent cooperation.
- Presence of periodontal pocket depth more than 4 mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrinAlso: mesoporous silica nanoparticles, hyaluronic acid nanoparticles, pomegranate (punica granatum) nanoparticlesplatelet rich fibrin is obtained by removing the middle layer from a centrifuged blood sample and is rich with platelets that plays an important role in tissue regeneration mesoporous silica nanoparticles are high surface area and excellent biocompatibility and enhance the outcome hyalurnic acid nanoparticles are high water capacity and involved in cell proliferation and adhesion and help in tissue regeneration pomegranate nanoparticles has anti-inflammatory and antibacterial effect and also help in tissue proliferation and regeneration | Procedure or surgery | Hyaluronic Acid Nanoparticles scaffold (HA), Mesoporous Silica Nanoparticles scaffold (MSN), Platelet Rich Fibrin (PRF only), Pomegranate ( punica granatum) Extract Nanoparticles scaffold |
Primary outcome
apical closure assessed radiographically
Time frame: 12 months after treatment
radiographic evaluation of apical closure as reduction or elimination of the apical opening of the root
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- evaluate the antimicrobial effectiveness of two irrigation medication protocolsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. share clinical and radiograpjic outcomes with qualified researches
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich fibrin in people with Necrotic Immature Permanent Incisors, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apical closure assessed radiographically (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.